Overview

G&L Healthcare Advisors was engaged to provide Good Manufacturing Practice (GMP) quality assurance support to a client operating a Phase I GMP unit specializing in cell therapy. 

The client had experienced an unsuccessful audit and required assistance in remediation activities to ensure compliance with current Good Manufacturing Practice requirements. 

The client sought to implement corrective measures and demonstrate their commitment to auditors while preparing for a re-qualification audit.

Challenges

The client faced several challenges, including:
Audit findings and compliance gaps: The client had been cited for several deficiencies during their audit, particularly regarding their Quality Management System (QMS) and oversight of cell therapy operations, which posed a risk to their ability to comply with cGMP standards.
Team training and process alignment: The client’s team required comprehensive cGMP training to align their practices with regulatory expectations and ensure proper execution of Phase 1 unit operations.
Third-party vendor oversight: The client needed to ensure that their third-party vendors were also compliant with GMP standards, particularly given their involvement in critical cell therapy processes.
Deviation management and CAPA implementation: Addressing audit findings required efficient deviation resolution and Corrective and Preventive Action (CAPA) management to prevent the recurrence of issues and achieve long-term compliance.

G&L’s Approach and Solution

Within this engagement, G&L employed a targeted approach to resolve the client’s GMP challenges and ensure compliance for future audits. Key activities included:
GMP compliance training: G&L provided in-depth GMP training for the client’s team members, ensuring they understood regulatory requirements and the practical steps needed to maintain compliance.
Technical oversight of cell therapy operations: G&L provided technical oversight for cell therapy processes, including detailed batch record reviews to ensure all manufacturing and documentation practices met GMP standards.
Third-party vendor audits: G&L conducted multiple vendor audits to ensure that external partners were also aligned with the necessary GMP requirements, reducing the risk of non-compliance from outsourced activities.
Person-in-plant support: G&L experts provided on-site support to oversee day-to-day operations, ensuring real-time adherence to GMP practices and facilitating immediate corrective actions as needed.
Deviation resolution and CAPA support: G&L assisted in the resolution of deviations identified during the audit and supported the implementation of CAPA plans to address the root causes of compliance issues.

Impact and Outcomes

As a result of G&L’s support and expertise:
Successful audit outcome: The client successfully passed the re-qualification audit, demonstrating their ability to meet cGMP standards for their Phase I cell therapy unit.
New business opportunities: The implementation of a robust QMS opened up new business opportunities for the client, as their improved compliance positioned them for future growth.
Ongoing collaboration: The client extended their collaboration with G&L for ongoing support, including discussions about assisting with the U.S. Food and Drug Administration (FDA) site accreditation for future Phase II activities.